COVID19 OutcomeS in Myeloma and the Impact of VaCcines (COSMIC)

ASH Research Collaborative

Status

Active, not recruiting

Conditions

Multiple Myeloma

Treatments

Other: Patient Reported Outcomes

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05831787

ASH RC DH 2022-00001

Details and patient eligibility

About

The COVID-19 pandemic has had an outsized impact on individuals with underlying social and medical vulnerability, leading to increased rates of severe disease, hospitalization, and death in these groups. Participants with underlying immune compromise, such as those with multiple myeloma, represent one such group. The advent of vaccines against SARS-CoV-2 has significantly limited morbidity and mortality across all groups, but the effectiveness of vaccination in individuals who are less likely to mount sufficient antibody response is uncertain. For this reason, booster vaccines have been recommended for those with underlying immune compromise. However, several key gaps remain in our understanding of how to best protect these individuals.

There is a dearth of real-world evidence about the effectiveness of vaccination and boosters in patients who are immunocompromised, and very little information specifically about the recently approved mRNA boosters. Additionally, rates of vaccination and booster uptake in the United States remain low. A rapid, decentralized method of ascertaining information related to booster vaccine response and adverse events related to vaccines and COVID-19 infection is critical not only to answer questions about the booster vaccines, but to develop an infrastructure for answering similar questions about future vaccines or other diseases.

Full description

The purpose of this project is to implement and establish the feasibility of a decentralized real-world evidence study network for patients with multiple myeloma and to monitor outcomes related to COVID-19 infection in this immunosuppressed population. Subjects with multiple myeloma will be invited to participate. The electronic portal will handle all consenting activities. Participants will be asked to complete specific study procedures electronically, including permission for electronic health record (EHR) data transfer. Participants will be asked to complete electronic questionnaires periodically.

Enrollment

200 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of multiple myeloma per the International Myeloma Working Group and currently receiving active treatment for any phase of the disease, including initial therapy, maintenance, or relapsed disease.
Access to the internet
An active patient portal (or willingness to activate)
Willing to electronically sign the study-specific informed consent and authorization form

Exclusion criteria